EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), is touting the results of a meta-analysis demonstrating that its Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device significantly improves patients’ quality of life (HRQL), while reducing their reliance on proton pump inhibitor (PPI) drugs.

Background

It’s only a couple of weeks since we covered the news that EGS had gained FDA clearance for an updated version if its clever EsophyX® device and here they are again, supporting the TIF procedure with some convincing clinical data.

Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair another treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.

Over 17,000 TIF patients have been treated worldwide since EsophyX® device clearance in 2007. More than 60 peer-review papers from over 50 centers have been published documenting consistent outcomes on over 1,100 unique study patients.

For this newly presented meta-analysis, the investigators used research databases PubMed, Embase, and SCOPUS to examine data from three RCTs and seven cohort studies from the past eight years that examined the TIF procedure and outcomes at least six months after the procedure.

Patients that had the Transoral Incisionless Fundoplication (TIF) procedure experienced a significant reduction in GERD-HRQL scores compared to patients treated with PPIs. The pooled prevalence for complete discontinuation of PPI therapy was 70%. Post-TIF procedure, a greater number of patients had reduction of distal esophagus acid exposure and healing of erosive esophagitis.

The meta-analysis is being presented as a poster (SU1137), at the Digestive Disease Week (DDW) annual meeting in San Diego, California.

Investigator comments

“Our research further validates the significant benefits of transoral incisionless fundoplication, demonstrating that the procedure has, since its introduction, effectively treated the underlying cause of GERD while ending patients’ reliance on PPI,” said Lauren B. Gerson, MD, MSC, gastroenterologist at California Pacific Medical Center in San Francisco. Dr. Gerson presented the meta-analysis in a poster session at DDW, along with Karim S. Trad, MD, Clinical Professor of Surgery with The George Washington University School of Medicine & Health Sciences.

Company comments

“This meta-analysis provides solid clinical evidence that TIF procedure with the EsophyX device is an excellent choice in bringing relief to GERD patients, providing an incisionless, effective alternative to potentially damaging PPI treatment,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We thank Dr. Gerson and Dr. Trad for their meticulous research and for their valued contribution to the field of GERD treatment.”